MXPA00001257A - Composition and method of treating cancer with tannic acid and tannin complexes - Google Patents

Abstract

A pharmaceutical composition including tannic acid and tannin complexes, a method of treating cancer with tannic acid and tannin complexes, and a method of making a medicament for treating cancer is disclosed.

Description

COMPOSITION AND METHOD FOR THE TREATMENT OF CANCER WITH TANIC ACID AND TANIN COMPLEXES FIELD OF THE INVENTION The present invention relates to pharmaceutical compositions comprising tannic acid or tannin complexes, and to a method of treating cancer with tannic acid or tannin complexes.

BACKGROUND ART Tannic acid and tannin complexes are found in the trunk of some of the Musaceae family plants, ie, Musa Paradi sia ca, Musa Ca vendi sh Dwarf, and related to Linnaean classifications. Tannic acid is known to be used in a diagnostic test for the detection of cancer. For example, Macartney et al. in J. Pa thol.

(ENGLAND) September 1979, 129 (1) p. 13-20.

"Intracellular filaments in human cancer cells: a histological study" (by its acronym in English "Intracellular filaments in human cancer cells: a histological study"), describes that .REF-: 32740 distribution of intracellular filamentous systems in human breast and colon cancers, have been demonstrated by means of staining technique by grinding dye of phosphomolybdic acid-tannic acid. The staining associated with the plasma membrane is prominent in breast carcinomas and is stronger in anaplastic tumors. Strong staining is also seen in cells at the margins of tumors where malignant cells are invading the surrounding tissues. In colon carcinomas, the filaments are mainly restricted in the tissue region of the cells, but the differentiation is accompanied by the development of the circumferential staining of the cell membrane. The results are discussed in relation to microscopic immunohistochemical and electron studies of contractile proteins in non-muscular cells. Harlos et al. in J. Cancer (DENMARK) Apr. , 1978, 21 (4) p. 413-7, describes "A comparison between the assays for the electrophoretic mobility of the macrophage (MEM) and the electrophoretic mobility of the fixed tannin erythrocyte (FTEEM) in the detection of cancer" (for its abbreviations in English "Comparison bet in the marophage electrophoretic mobility (MEM) and the fixed tanned erytrocyte electrophoretic mobility (FTEEM) test in the detection of cancer "). When the peripheral lymphocytes of patients with a history of cancer are incubated with the encephalitogenic factor (EF), in 90% of the cases, the resulting products reduce the negativity of the pure surface of macrophages in guinea pigs, used as cellular detectors, as it is revealed in the electrophoretic mobility assay of the macrophage (MEM). The MEM trial is positive in 36% of people with no cancer history. The erythrocytes of sheep tannins fixed with formaldehyde, have been used as cellular detectors instead of the guinea pig macrophages, in an assay of electrophoretic mobility of fixed erythrocyte tannin (FTEEM), with lymphocyte products identical to those used in the tests. MEM. In patients with a history of cancer, positive results are obtained in 28 of the 42 cases with the FTEEM trial compared with 32 of 42 in the MEM trial. In people with no cancer history, negative results are obtained in 16 of the 18 cases with the FTEEM trial, compared with 12 of the 18 in the MEM trial in the present series, and 51 of g ^^ * g? gt ^ &! «teg 69 in more extensive series. These differences are not significant. The cases in which discrepancies between the two trials are revealed are discussed in terms of individual case histories. Tannic acid has been shown to inhibit tumor promotion with 12-0-tetra-decanoyl-phorbol-13-acetate (TPA). Perchellet et al., Ba si c Li fe Sci. (UNITED STATES) 1992, 59 p. 783-801, describes that phenols from plants that naturally originate with antimutagenic and anticarcinogenic activities were tested for their ability to inhibit the biochemical and biological effects of the potent tumor promoter 12-0-tetradecanoyl-phorbol-13-acetate (TPA) in epidermis of mice in vivo. When applied topically to the skin of mice, tannic acid (TA), ellagic acid, and various derivatives of gallic acid, all inhibit the activity of ornithine decarboxylase induced by TPA, the production of hydroperoxide, and the synthesis of DNA, three biochemical markers of tumor promotion. the skin. In a two-step initiation promotion protocol, the same phenolic compounds also inhibit the incidence and performance of skin tumors promoted by TPA. Ramanathan et al. in "Cytotoxic effect of plant polyphenols and fat-soluble vitamins in human malignant cultured cells", ("Cytotoxic effect of plant polyphenols and fat-soluble vitamins on malignant human cultured cells", Cancer Le tt (NETHERLANDS) March 15, 1992, 62 (3) pp. 217-24, describes in vitro studies, which show that the various flavonoids, tannic acid, gallic acid and fat-soluble vitamins inhibit lymphoma cell growth HeLa and Raji The directed inhibition exhibited by these compounds was similar for both cell lines, and their growth was in an inhibited dose dependent manner Butein, () microM), the most potent anti-proliferative agent, exerts 30% inhibition of growth and was more effective in HeLa cells.My retinol () M completely inhibits cell proliferation.Tanic acid was twice as potent as its monomer gallic acid. Consideration of the structure of activity, the carbon-2-3 double bond, of the flavonoid molecule was important for its activity. The flavonoid aglycones were more effective than their corresponding glycosides in the suppression of cell growth in vitro. No results were presented in LIVE. Athar et al., "Effect of tannic acid in the diet on the epidermis, lung and intestinal flora of the polycyclic aromatic hydrocarbon metabolism and tumorigenicity in Sencar mice", (for its acronym in English Effect of dietary tannic acid on epiderman, lung, and forestomach polycyclic aromatic hydrocarbon metabolism and tumorigenicity in Sencar mice ",) Cancer Res. (UNITED STATES) Nov. 1, 1989, 49 (21) p.5744-8, describes that tannic acid inhibits the mutagenicity of the various aromatic hydrocarbons polycyclics (PAHs) and their diol-epoxide compartment regions Studies have shown that when applied topically to Sencar mice, tannic acid causes substantial inhibition of epidermal PAH metabolism, the subsequent formation of PAH-DNA approach, and PAH-induced skin tumorigenesis None of the above publications describe that tannic acid is used for the treatment of cancer. Current standards include surgery, chemotherapy and radiation therapy, which often present patients with unpleasant side effects, which depending on the type of cancer, may have limited effectiveness as treatments. There is a need in the art to provide effective treatments for many types of cancer, with limited unpleasant side effects. The tannic acid pharmaceutical composition and the method of the present invention overcome deficiencies in the prior art compounds.

Description of the Invention It is an object of the present invention to provide a pharmaceutical composition for the treatment of cancer comprising tannic acid or tannin complexes from the sap of a Musa cea e Family plant and a pharmaceutically acceptable carrier. The plant is preferably selected from the group consisting of Musa pa ra di si a ca (banana); Musa Ca vendi sh Dwarf (banana), varieties and mixtures thereof. It is an object of the present invention to provide a method of cancer treatment comprising administering an effective amount of a pharmaceutical composition comprising tannic acid or tannin complexes from natural or synthetic sources. It is preferred that the pharmaceutical composition be administered at least once daily, and more preferably, that the composition be administered four times a day. The pharmaceutical composition of the invention is used. advantageously to treat any cancer condition. It is understood that the invention includes a method of making a medicament for the treatment of cancer. The invention includes a pharmaceutical composition comprising tannic acid and tannin complexes, and the treatment of a cancer patient with a composition according to the invention. The types of cancer that can be treated with the composition and method of the present invention include, but are not limited to the following: nasal cavity, paranasal sinuses, nasopharynx, oral cavity and squamous cell carcinomas oropharynx and adenocarcinomas; oral lymphomas; adenoid cystic carcinoma; paragangliomas; squamous cell carcinoma, adenocarcinoma, large cell carcinoma (undifferentiated), and small cell carcinoma of the lung; mediastinal thymomas, lymphomas and neurogenic carcinomas; squamous cell carcinoma and adenocarcinoma of the esophagus; adenocarcinoma of the stomach; ductal or duct adenocarcinoma, cystadenocarcino to mucinosus, arcuate cell carcinoma, unclassified large cell carcinoma, small cell carcinoma, and pancreatoblastoma of the pancreas; hepatocellular carcinoma, hepatoblastoma, cholangiocarcinoma, cholangiocellular carcinoma, cystadenocarcinoma, squamous cell carcinoma, angiosarcoma, hemangioendothelioma, leiomyosarcoma, malignant eswanoma, fibrosarcoma, malignant fibrous histiocytoma, lymphoma, osteosarcoma, rhabdomyosarcoma, and liver mesenchymal carcoma; adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, oat cell carcinoma (oat) (small cells), carcinosarcoma, malignant lymphoma, malignant melanoma, radbomyosarcoma, fibrous histiocytoma, and angiosarcoma of the gallbladder; adenocarcinoma, fibrosarcoma, leiomyosarcoma, liposarcoma, angiosarcoma, lymphangiosarcoma, lymphoma, and neurofibrosarcoma of the small intestine; adenocarcinoma, mucinous adenocarcinoma, adenocarcinoma of signet ring cells, squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, unclassified carcinoma, argentatin carcinoid tumor, non-argentatin carcinoid tumor, composite carcinoid tumor and ^? - leiomyosarcoma of the large intestine; squamous cell carcinoma, temporal (cloacogenic) carcinoma, adenocarcinoma, papillary villous carcinoma, and mucinous adenocarcinoma of the anus; renal clear cells, granular cells and sarcomatoid carcinoma; nephroblastoma; temporary cell carcinoma of the uterus; carcinoma of the bladder; adenocarcinoma of the prostate; squamous cell carcinoma and cervical adenocarcinoma; adenocarcinoma, cystadenocarcinoma, carcinoma and adenofibroma, cystadenofibroma, sarcoma and adenocanthoma of the ovary; papillary, follicular and medullary carcinoma of the thyroid; adenoma and carcinoma of the parathyroid gland; adenoma and carcinoma of the adrenal cortex; fibrosarcoma, and liposarcoma, fibrous histiocytoma, squamous cell carcinoma, and soft tissue sarcoma; leiomyosarcoma, and muscle tissue rhabdomyosarcoma: osteogenic sarcoma, fibrosarcoma, fibrous histiocytoma, and bone chondrosarcoma; angiosarcoma, lymphangiosarcoma, and Kaposi's sarcoma: malignant glomus tumor and hemangiopericytoma; synovial sarcoma and giant cell tumor of the tendon sheath; malignant tumor of the peripheral nerve cover, neurofibrosarcoma, malignant tumor of the triton, malignant glandular eswanoma, epitheloid eswanoma, malignant tumor of granular cells, sarcoma of clear or transparent cells of the nerve and malignant paraganglioma; chondrosarcoma and osteosarcoma; malignant mesencinoma; Hodgkin and not Hodgkin's lymphoma; cutaneous T-cell lymphoma; Burkitt's lymphoma; lymphoma of the primary nervous system; acute myelocytic, acute lymphoblastic, chronic myelocytic, chronic lymphoblastic, chronic myelogenous, acute myelogenous, acute promyelocytic, acute non-lymphocytic, acute monocytic; and myelocytic leukemia; retinoblastoma; choroidal malignant melanoma; macroglobulinemia; heavy chain disorders; and multiple myeloma. In an alternate embodiment, the present invention provides a method of chemical discoloration of N-acet-ilneuraminic acid from a cancer cell surface that allows recognition of cancer cells by the immune system in vivo, which comprises contacting said cancer cells. with tannic acid or tannin complexes.

The foregoing and other objects of the invention will become readily apparent to those skilled in the relevant art from the following detailed description and figures, wherein only the embodiments of the invention are shown and described, simply by way of illustration of the best way to carry out the invention. As is easily recognized, the invention is susceptible to modifications by a person skilled in the relevant art, without departing from the spirit and scope of the invention. The present invention relates to pharmaceutical compositions comprising tannic acid and tannin complexes or mixtures thereof, and a method of treating cancer with tannic acid and tannin complexes. The invention will now be described in a manner to facilitate the production and use of tannic acid compositions and tannin complexes for the treatment of cancer. The compositions of tannin complexes as used herein, mean hydrolysable tannins, such as sugar esters, usually glucose. What is known about the adhesion of cancer cells and their invasion and potential metastatic growth in human tumors? The tumor cells produce an external protective coating, which camouflages or hides the epitope structures of the cancer cells, so that the immune system can not recognize the cells. The protective coatings contain N-acetylneuraminic acid in a linear homopolymer of bound N-acetylneuraminic acid 2-8 (NeuNAc) which is referred to as polysialic acid (PSA). PSA is expressed in the adhesion molecule NCAM (Neural Cell Adhesion Molecule, for its acronym in English, Neural Cell Molecule Adhesion) and in most cell adhesion molecules. In the patient with cancer, PSA is found in extremely high blood levels, as well as linked to erythrocytes and other blood components vital to the immune response. It has been shown experimentally that PSA-NCAM drastically increases cell-to-cell distances and decreases potential adhesion in NCAM. One of the vehicles for this physiological change is the hydrated volume of PSA in PSA-NCAM against NCAM in adjacent cells. The presence of PSA decreases adhesion via a physical impairment of the contacts of the total membrane. These modulating effects of PSA are relevant to cell migration, establishment of temporary cell-cell contacts, and cell differentiation during embryonic development. In the patient with cancer, the presence of 1? ^ ^% S- < < - ^ y ^ y ^ ß Z. -! PSA is linked to a loss of potential adhesion, which facilitates invasive and metastatic growth of cells, as well as potential structural differentiation, and recognition of healthy cells in tumor cells, ie, neoplastic cells. . PSA is the main molecule involved in the masking of antigens specific tumors (TA), which are normally linked to the components of the immune system, decreasing the effectiveness of NCAM and other cell adhesion molecules, and induce the cell differentiation of cells. healthy cells in neoplasts. Thus, if one can obtain selective elimination of PSA from tissues and bloodstream where possible, the greatest limitation that makes cancer cure outside of operating conditions could be eliminated. This could allow blood to attack and destroy a tumor in many of the few forms of rejection of a transplanted organ. The tannic acid and the tannin complexes according to the present invention bind to and precipitate the bound N-acetylneuraminic acid in PSA-NCAM also as in the circulating blood and bind to the erythrocytes. Tannic acid recognizes the linear homopolymer of bound N-acetylneuraminic acid 28, with the amino group exposed at position five (5), as an amino acid chain (protein). The electron equivalents in the nitrogen group of PSA are covalently bonded to the carbonyl group of tannic acid, linking the chains of the tannic acid portion. The resulting blood is a very stable one with several resonance structures. See scheme I below.

N-Acetylneuraminic acid 25 Three moles of N-acetylneuraminic acid are bonded to each of the moles of tannic acid in solution. When this activity is studied, and the interesting property of PSA is considered to subject it to depolymerization under medium acidic conditions, this shows that the reaction between tannic acid and PSA (which leads to the precipitation of three moles of N-acid) -acetylneuraminic acid and all moles of tannic acid) is highly favored and facilitates the reaction. Tannic acid and tannin complexes act by the chemical discoloration of N-acetylneuraminic acid from the cell surface portion. Tannic acid therefore acts as an astringent. As long as it is done, tannic acid and tannin complexes affect the previously described cellular changes, allowing the immune system of the person's body to reject cancerous growth in many of the few forms of rejection of some foreign invader. The tannic acid and tannin complexes of the present invention expose epitopes of cancer cells that were previously camouflaged by PSA. At the same time, tannic acid and tannin complexes elevate the immune response by free circulation of the blood components from the bound PSA. The most important objective of PSA in this spread of a deficient immune condition in patients with cancer, is the macrophage, a cell that is not only phagocytosis of unfriendly cells, but also activates the cell-mediated and humoral immune response. It is believed that the cancer cell, by secreting N-acetylneuraminic acid and its polymerization in PSA, induces an immune deficiency, which is adversely affected by the action of tannic acid and tannin complexes. None of the exactly known start cancerous growths, but it is the conclusion of the inventor that cancerous growths induce immune deficiencies. The invention is not, however, restricted to this explanation of the theory of the invention.

Tannic Acid Product Production Method Thus, the tannic acid and the tannin complexes of the present invention can be formulated into pharmaceutical compositions for the treatment of cancer. The tannic acid and the tannin complexes according to the present invention can be produced from natural sources or can be produced synthetically. Sources of tannic acid are preferred from natural sources. To obtain the tannic acid extract from natural sources, the following procedure is followed. The tannic acid and the active tannin complexes are obtained, the stem of some of the plants of the Musa cea Family, for example, but not limited to Musa Para di si a ca, Musa Ca vendi sh Dwarf, and related to The Classifications of Lineo, are milled to extract the sap from the plant. The pulp is filtered from the sap to obtain a characteristic, transparent dark liquid. This liquid is preferably incorporated in a pharmaceutical preparation containing as its base: a 70% sorbitol solution (21%), partially hydrogenated olive oil such as that sold under the trademark Cremophor RH40 (8.8%), potassium sorbate (0.15%), methylparaben (0.038%), and propylparaben (0.013%) w / w (weight to weight). The lotification procedure is a standard operating procedure (SOP) approved by the Units íl-ß-- -rr- »-. to". ? r.

States Food and Drug Administration (FDA), Current Good Manufacturing Practices (CGMP), for liquid pharmaceuticals. The total percentage of tannic acid or tannin complexes in the final product should be approximately 2.5-20 percent. Preferably, the amount of tannic acid or tannin complex in the final product is about 3.0-10 percent of the concentration, more preferably it is about tannic acid / 5% tannin complexes based on the total concentration of 100% , when the active agent is in the presence of a pharmaceutical carrier.

If natural sources provide a percentage lower than 5%, food-grade tannic acid can be used to provide a 5% concentration. If the natural source provides a percentage higher than 5%, the product can be diluted and re-tested to ensure a concentration of 5%. To prepare tannic acid and tannin complexes from a synthetic source, the following lotification procedure is approved by the FDA, CGMP, SOP for pharmacists MMs-S • 2i liquids. The Food Grade Tannic Acid is dissolved in water together with the standard pharmaceutical preparation as described under the natural extract. The percentage of tannic acid in the final product is approximately 5 percent (5%). Tannic acid (C76H520? 8) can be synthetically produced as described in the references cited in the Merck Index nava. Edition., Abstract 9023, p. 1431, Merck Publishing Company 1989, (incorporated herein for reference in its entirety). In addition, the pharmaceutical compositions of the present invention are employed in compositions for systemic administration in humans and animals in unit dosage forms, such as tablets, capsules, pills, powders, granules, suppositories, sterile parenteral solutions or suspensions, non-parenteral solutions. sterile or oral solutions of suspensions or suspensions, oil in water or water in oil emulsions and the like, which contain adequate amounts of an active ingredient.

Any of the fluid or solid unit dosage forms can be easily prepared for oral administration. For example, the tannic acid compounds or tannin complexes of the invention can be mixed with conventional ingredients such as dicalcium phosphate, aluminum magnesium silicate, magnesium stearate, calcium sulfate, starch, talc, lactose, acacia, methyl cellulose and functionally similar materials as excipients or pharmaceutical carriers. A sustained release formulation can be used optionally. The capsules can be formulated by mixing the component with a pharmaceutical diluent, which is inert and this mixture is inserted into a hard gelatin capsule having the appropriate size. If mild capsules are desired, a suspension of the compound with an acceptable vegetable, light petroleum or other inert oil can be encapsulated by a machine in a gelatin capsule. Suspensions, syrups and elixirs may be used for oral administration of fluid unit dosage forms. A fluid preparation that includes oil can be used for oil soluble forms. A vegetated oil * such as corn oil, peanut oil or sunflower oil, for example, together with flavoring agents, sweeteners and some preservatives, produce a preparation aü ^^ = - áaá $ --- * & < 3 fluid acceptable A surfactant or surface activator can be added to the water to form a syrup for fluid unit dosages. Aqueous alcoholic pharmaceutical preparations that can be used, have an acceptable sweetener such as sugar, saccharin or biological sweetener and a flavoring agent in the form of an elixir. Pharmaceutical compositions for parenteral administration and suppositories can also be obtained using standard techniques in the art. Tannic acid and tannin complexes may be present in the reservoir either alone or in combination with pharmaceutical carriers. Pharmaceutical carriers acceptable for the purposes of this invention are known carriers that do not adversely affect the drug, host or material comprising the drug delivery device. Suitable pharmaceutically acceptable carriers include sterile water, saline, dextrose, dextrose in water or saline; condensation products of olive oil and ethylene oxide that combine approximately 30 to approximately 35 moles of ethylene oxide per mole of olive oil; liquid acid; lower alkanols; vegetable oils such as corn oil; peanut oil; sesame oil and the like, with emulsifiers such as mono or diglycerides of fatty acids, or phosphatide, for example, lecithin and the like; glycols, polyalkylene glycols; aqueous medium in the presence of a suspending agent, for example, sodium carboxymethyl cellulose; sodium alginate; poly (vinylpyrrolidone); and the like; alone or in combination with distribution agents such as lecithin; polyoxyethylene stearate; and the similar ones. The carrier may also contain adjuvants such as preservatives, stabilizers, humectants, emulsifiers and the like. Additional formulations for administration can be made in accordance with methods and amounts known in the art as set forth in Remington's Pharmaceutical Sciences, 18th. Ed. Wiley Publishing (1990) here incorporated for reference in its entirety.

Table I below represents recommended dosages, methods and times of administration and a preferred pharmaceutical formulation in accordance with the present invention.

TABLE 1 Recommended Dosages of Banana Syrup Before meals and at bedtime Weight Height 4 times a day (mi) Dosages 1. Stage 1 of Cancer and other alterations during the 3 months - used as prophylactics in cancer and other conditions.

M = fü- ^ i-á-S Stage 2 and 3 of the cancer for 3 months and continue with dosages (1) j | §í &another 3 months. If the cancer of the patient has been treated with chemotherapy or radiotherapy, this dosage is for three months and three months with dosages (2). Then, three additional months with dosages (1). (9 months in total). Stage 4 cancer, are terminal care, for one year. All these dosages can be modified by the physician or specialist, using methods known in the art, after reviewing monthly. The range of dosages from about 4 to about 200 ml. The maximum dosages for height and weight appear in column 4 above.

Examples The following examples are proposed to show the use of compositions and methods of the invention to treat a variety of cancers. These examples show how the composition and method can be used, but are not proposed to limit the use of osmosis. The following clinical data & } voluntary patients during the clinical trials in Cuba. A concentration of 10% tannic acid was used in all the clinical studies listed below.

Patient # 1: 79 years old, male. Prostate carcinoma, a permanent catheter was inserted surgically. Cancer can not be operated due to the vascular condition. The therapy according to the present invention was administered at the maximum dosage for an initial period of three months in accordance with "dosing administration". Two weeks after the initiation of therapy according to the invention, the catheter was removed. The cancer was cured and the patient returned to normal activities with the first treatment period of three months. After which, he used the product for an additional 7 months.

Patient # 2: 43 years old, female. Carcinoma of the chest The surgery was performed on January 11, 1982, in the left breast. The problem of growth - «.- • - - metastatic was important. The therapy according to the invention was started for a minimum period of 3 months, based on the weight of the patient and the criterion of height. No additional cancerous growth was detected in any part of his body.

Patient # 3: 51 years old, female. Carcinoma of the chest Cancer was diagnosed in the left breast at the Cancer Institute of Havana (for its acronym Cancer Institue of Havana). The tumor is 5 cms by 5 cms. The patient refused breast removal and the therapy according to the invention was administered. The therapy according to the invention was initiated based on weight / height criteria at maximum levels (see Table 1, column 4). The tumor decreased in size after the first three-month interval to the point at which it was very difficult to detect by manual examination. The therapy according to the invention continued in accordance with the "dosing administration" for a period of one year. The cancer never returned until today.

Patient # 4: 54 years old, female. Colon carcinoma He was administered 72 dosages of chemotherapy simultaneously with the therapy according to the invention. His blood work through chemotherapy / therapy was normal. She continued with the normal revisions and all were negative. The maximum therapy according to the invention was administered together with the chemotherapy.

Patient # 5: 52 years old, female. Carcinoma of the uterus. The surgery to remove the uterus was recommended and the operation was planned. After the patient's opening, metastatic growth was detected through the internal organs. The uterus was not removed from the patient and was classified as terminal. The maximum therapy was administered according to the levels of the invention for a period of one year. He was cured of cancer in all parts of his body. The annual review has not confirmed recidivism.

Patient # 6: 50 years old, female. Carcinoma of the chest Operated for the removal of the left mammary gland in 1981. In 1982 it was found that the gland infected with cancer. The was not an option because metastasis was detected in the skeletal system, lungs and liver. It was classified as a terminal. Maximum therapy according to the invention was applied for a period of one year, in which, it was cured of cancer in all organs. The semi-annual reviews did not reveal incidence.

Patient # 7: 67 years old, female. Carcinoma of the uterus. The cancer was penetrating in all parts of the organ. The radiation therapy was prescribed. She had a violent reaction to the radiation she rejected after treatment. It was subjected to therapy according to the invention at a maximum dosage for a period of one year. No other treatments were applied. The semi-annual reviews did not reveal recidivism.

Patient # 8: 2 year old boy. Acute lymphocytic leukemia. Patient classified as terminal. The therapy according to the invention was initiated by administration in the form of drops because the patient had difficulty swallowing. The administration continued until the patient was able to ingest the dosages later. of 1 week. The therapy period was for one year at maximum dosages as weight / weight criteria. The patient initially showed signs of being cured. The recurrence occurred two years after the termination of the therapy through a process in which the leukemia cells were embedded in the testicles. The cyst broke at the time of the recidivism. The therapy according to the invention was administered and the patient was cured through a long period of one year's treatment. On this date, all revisions have been negative. The patient is now 17 years old.

Patient # 9: 56 years old, female. Colon carcinoma He experienced blockage of the intestines. The step diverted the rejection but the tumor was not removed. The tumor was so large that elimination was not feasible. Surgery was performed to extend his life without hope of cure. The doctors opted for *** 5- * "-y * ^ - * The bypass chemotherapy and fears of radiation therapy result from the extension of the therapy that could be devastating.The therapy according to the invention was administered at a maximum level for a period of one year, the tumor disappeared and has not returned.

Patient # 10: 38 years old, female. Carcinogenic lesion of the tongue. The lesion was about the size of a penny. During the course of six months, conventional treatment was not effective. The lesion grew deep in the tongue. The therapy according to the invention was administered for 3 months in stage 1 with a weight / height criterion. The lesion was healed and the tissue of the tongue restored to normal. He did not reoffend.

Patient # 11: 64 years old, male. Penile carcinoma Surgery was performed to remove the sexual organs (testicles and penis). It was found that the cancer metastasized and the patient was classified as terminal. The therapy according to the invention was administered at maximum levels immediately after the surgery for one year. He has not had recidivism and was cured of the cancer that was diagnosed after him. Surgery.

Patient # 12: child of 5 years of age. Acute lymphocytic leukemia. The therapy according to the invention was administered at maximum levels in accordance with the weight / height criterion for one year. The patient initially showed signs of being cured. The recidivism occurred approximately 2 years after the termination of the therapy according to the invention through a process in which the leukemia cells were encased in the testicles. The cyst broke at the time of the recidivism. As in Patient # 8, the therapy according to the invention was administered and readministered over a period of one year. The patient was cured and the subsequent revisions have been negative. The patient is now 20 years old.

Patient # 13: 4 years old, female. Acute lymphocytic leukemia. It has been administered chemotherapy. The reaction of the patient to chemotherapy was very violent. There is no improvement with chemotherapy. The therapy according to the invention was administered and immediately the blood work exceeded returned to normal parameters. The therapy according to the invention was administered for one year at maximum levels in accordance with the weight / height criterion. The patient (now 19 and married) was cured of cancer and there has been no recurrence.

Patient # 14: 21 years old, male. Hodgkin lymphoma. Chemotherapy was initially applied without the improvement of the condition of the condition and a devastating reaction to chemotherapy. With patient authorization, the chemotherapy was discontinued and the therapy according to the invention was administered with the weight / height criterion for one year. Even though the patient was considered terminal prior to the therapy according to the invention, he was cured of the disease. The subsequent revision has been negative and there has been no recidivism.

Patient # 15: 58 years old, female. Carcinoma of the chest The left mammary gland was removed and due to the fear of metastasis, the therapy according to the invention was administered for a period of one year, in accordance with the weight / height criterion. At the end of the therapy, according to the invention, the cancer was not detected. Two years after the therapy according to the invention, an annual review, it was discovered that she had carcinoma of the uterus. The therapy according to the invention was readministered for a period of one year. She was cured of uterine cancer and again the reviews have been negative. Great importance was expressed about the possibility of metastasis 5 but it did not occur.

Patient # 16: 59 years old, female. Chest carcinoma with metastasis in both lungs and lymph nodes. The specialist who attended it, detected the cancer initially in the lungs, but the primary or main site was in the chest. The patient was classified as terminal. The therapy according to the invention was administered at maximum levels of 5 in accordance with the weight / height criterion for a ^^ & "-Yes • ^^ fXi SM? ^ & ^ h period of one year and end of the therapy in accordance with the invention, the Doctor declared the patient cured, and was impressed by the therapy. negative to cancer.

Patient # 17: 4 years old, female. Monoblastic leukemia. Chemotherapy was given without improvement in her condition, but they were devastating in her. The maintenance of the oral chemotherapy was discontinued by the parents with only the three-month periodic treatment with progressive reviews. No improvement was reported in his condition. The therapy according to the invention was started at maximum levels in accordance with the weight / height criterion for a period of one year. She was cured of monoblastic leukemia and has not been a recidivist.

Patient # 18: 41 years old, female. Liposarcoma of the right thigh. He underwent two unsuccessful surgeries to remove the cancer with the returning condition each time. The amputation of the patient was recommended for survival, but the patient was amputated. rejection. The therapy according to the invention was administered at maximum levels in accordance with the weight / height criterion for a period of one year. She was cured of cancer, and has not had recidivism. The patient is 54 years old and is fine.

Patient # 19: 51 years old, female. Multiple myelomas The patient was not able to walk due to the metastasis in hip and ribs. No other therapy was administered, but therapy was given at maximum levels for a period of three months. The doctors examined the X-rays that were taken at the end of the therapy, and all concurred in the current regeneration of the skeletal tissue and structure. The patient's relatives never revealed to her that she had cancer. The therapy was designed for a period of one year, but the patient refused treatment after three months, because she gained weight. The patient died four years after myeloma.

Patient # 20: 30 years old, male. Hypernephroma (Kidney Cancer). The Chief of Oncology and related to the patients were the specialists who attended. The metastasis occurred in both lungs and hip ^ liver and brain were also suspect). The patient was given less than a month to live and classified as a terminal. The therapy according to the invention was administered at maximum levels in accordance with the weight / height criterion for a period of one year. After 20 days of therapy according to the invention, hip regeneration occurred, and after one month, the patient returned to normal daily activities. At three months, the therapy was discontinued due to patient control beyond the subjects. The patient lived for two years after the therapy, and never experienced any pain from the recidivism.

Patient # 21: 27 years old, male. Bladder carcinoma The patient was the first to receive therapy (in 1951). The urologist's attention, diagnosed carcinoma, which was confirmed by two other specialists. The three specialists performed a cystiscopic examination. The carcinoma was located in the right wall of the neck of the bladder. The patient's symptoms were painful when urinating with high blood levels in the urine. Surgery was recommended by the three specialists. The patient refused surgery, and the therapy according to the invention was administered at maximum dosages in accordance with the weight / height criterion. Regular reviews were made at three months, which included a cytoscopic examination each time, and in the first review, the carcinoma decreased in size. At 10 months, the patient freed himself from the care of the specialists and declared himself cured of the cancer spontaneously (the specialists did not know about the therapy). The patient was married in a short time after, had four healthy children, and is currently 71 years old and has not suffered recurrences.

Patient treatments can also is made with a composition according to the invention wherein the composition comprises about 5% tannic acid or tannin complexes. f fff ft -, a ^ ^^^^ - ^^^ = ^^ Patient # 22: 50 arff-s of age, male. Adenocarcinoma of the large intestine. The therapy according to the invention was administered, with a 5% tannin complex being provided to the patient. Tumor reduction was observed as a result of six months of treatment.

Patient # 23: 52 years old, male. Squamous cell carcinoma of the gallbladder. The therapy according to the invention was administered with a 5% tannin complex being provided to the patient. Tumor decline was observed as a result of five months of treatment.

Patient # 24: 54 years old, male, Ductal adenocarcinoma or pancreatic duct. The therapy according to the invention was administered, with a 5% tannin complex being provided to the patient. Growth was greatly delayed as a result of eight months of treatment.

Patient # 25: 60 years old, female. Cervical squamous cell carcinoma. The therapy according to the invention was administered with a 5% tannin complex being provided to the patient. Tumor decrease was observed as a result of six months of treatment.

Patient # 26: 32 years old, male. Osteogenic sarcoma Subsequent to the amputation of the patient's leg, the sarcoma appeared to metastasize. The therapy was administered according to the invention, with a 5% tannin complex being provided to the patient. The remission of the metastatic neoplasm was observed as a result of six months of treatment.

Patient # 27: 45 years old, female. Leiomyosarcoma of the small intestine. The therapy according to the invention was administered, with a 5% tannin complex being provided to the patient. Remission was observed as a result of five months of treatment.

In short, it provides a composition that includes tannic acid and tannin complexes, and a cancer treatment method with tannic acid and tannin complexes, which show effective results in the treatment of cancer.

The purposes of the foregoing description and examples are to illustrate some of the embodiments of the present invention without implying any limitation. It will be apparent to those skilled in the art, that various modifications and variations may be made to the composition and method of the present invention, without departing from the spirit and scope of the invention. All patients and publications cited here are incorporated by reference in their entirety. s ^ k.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is that which is clear from the present invention of the description.

Having described the invention as above, the content of the following is claimed as property.

Claims (31)

1. A method of treating a cancer sensitive to tannic acid in a patient, characterized in that it comprises administering to a patient in need thereof, an effective amount of a composition comprising tannic acid.

2. The method of claim 1, characterized in that said composition further comprises sugar.

3. The method of claim 2, characterized in that said composition further comprises honey.

4. The method of claim 2, characterized in that the sugar is sorbitol.

- • «? -« • - - ** «" 5. The method of claim 2, characterized in that said composition further comprises 30% honey.

. The method of claim 1, characterized in that said composition comprises 5% tannic acid, 70% sorbirol solution (21%), partially hydrogenated olive oil (8.8%), potassium sorbate (0.15%) methyl paraben ( 0.04%), and propylparaben (0.013%) in weight / weight.

7. The method of claim 1, characterized in that the patient is an animal.

8. The method of claim 1, characterized in that said patient is a human.

9. The method of claim 1, characterized in that said composition further comprises a pharmaceutically acceptable carrier.

^^ Sa-sEÍ-íisS '* 10. The method of claim 9, characterized in that said composition is administered at least once daily.

11. The method of claim 9, characterized in that the composition is administered four times daily.

12. The method of claim 9, characterized in that the composition is administered orally.

13. The method of claim 9, characterized in that said composition is administered parenterally.

14. The method of claim 9, characterized in that said composition is administered as a suppository. 41

15. The method of claim 9, characterized in that said composition comprises about 2.5-20 percent tannic acid.

. 16. The method of claim 9, characterized in that said composition comprises about 5 percent tannic acid.

17. A method of treating a cancer sensitive to tannin complexes in a patient, characterized in that it comprises administering to a patient in need thereof, an effective amount of a composition comprising tannin complexes.

18. The method of claim 17, characterized in that said composition further comprises sugar.

19. The method of claim 18, characterized in that said composition, furthermore, x g | g | . gg¡¡ | includes honey

20. The method of claim 18, characterized in that the sugar is sorbitol.

21. The method of claim 18, characterized in that said composition further comprises 30% honey.

22. The method of claim 17, characterized in that said composition comprises 5% tannin complexes, 70% sorbitol solution (21%), partially hydrogenated olive oil (8.8%), potassium sorbate (0.15%) methylparaben (0.04) %), and propylparaben (0.013%) in weight / weight.

23. The method of claim 17, characterized in that the patient is an animal. a9

24. The method of claim 17, characterized in that said patient is a human.

25. The method of claim 17, characterized in that said composition further comprises a pharmaceutically acceptable carrier.

26. The method of claim 25 characterized in that said composition is administered at least once daily.

27. The method of claim 25, characterized in that the composition is administered four times daily.

28. The method of claim 25, characterized in that the composition is administered orally.

29. The method of claim 25, characterized in that said composition is administered parenterally

30. The method of claim 25, characterized in that said composition is administered as a suppository.

31. The method of claim 17, characterized in that said composition comprises about 5 percent tannic acid.